# FDA 483 - SUCO, Inc. - August 02, 2017

Source: https://www.globalkeysolutions.net/records/483/suco-inc/60a0dd52-6860-457d-af2e-9daf6788fc40

> FDA 483 for SUCO, Inc. on August 02, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUCO, Inc.
- Inspection Date: 2017-08-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: SUCO, Inc., a drug manufacturer in Silver Spring, MD, was cited for significant deficiencies in its production and process controls. The inspection revealed a lack of written procedures, inadequate batch production records, failure to determine theoretical yields, uncalibrated equipment, and insufficient identity testing for drug product components. These issues indicate a systemic failure to ensure drug product quality, strength, and purity.

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## Related Officers

- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.globalkeysolutions.net/companies/suco-inc/72353a3f-ae10-40e9-a987-e16d075d9122

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e